MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA SR; PACEMAKER

Model Number	359531
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the follow up in (b)(6) 2019, the programmer showed that the pacing rate was 0.Pacing can be seen on dynamic electrocardiograms.Evia sr was explanted and replaced.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the pacemaker was interrogated and the memory content was analyzed indicating no anomalies.However, it was noted that the pacing percentage was 0 percent.Please note that a pacing percentage of 0 percent does not necessarily mean that no pacing pulses were delivered.In general, a pacing percentage of less than 0.5 percent will be rounded to 0 percent.This does not represent a device malfunction.The header of the device was analyzed.The set screw could be easily screwed in and out, there was no foreign material inside the header bore.All dimensions of the header bore were within the range requested by the standard specifications.Also the spring element of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal in amplitude and frequency as programmed.There was no indication of a device malfunction.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.

• Brand Name: EVIA SR
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8703440
• Report Number: 1028232-2019-02381
• Device Sequence Number: 2211440
• Product Code: NVZ
• UDI-Device Identifier: 04035479101336
• UDI-Public: 04035479101336
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 359531
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization